Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2026

Conditions
Suspected Damage to Fetus From Biologic Agents
Interventions
OTHER

clinical evaluation

\- In children: general clinical evaluation, birth weight, APGAR, ECG, admission to ICU, hospital admissions in perinatal age, presence of malformations; complete blood count, inflammatory index, complement, antibiotic treatment, brain ultra-sound, presence of infection, presence of sepsis, presence of necrotizing enterocolitis, growth curve, presence of recurrent infections, developmental milestones, response to vaccines, admission to hospital in the first year of life.

Trial Locations (1)

20132

RECRUITING

IRCCS ospedale san raffaele, Milan

All Listed Sponsors
lead

IRCCS San Raffaele

OTHER